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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05221190
Other study ID # Anesthetic techniques
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2021
Est. completion date March 3, 2022

Study information

Verified date November 2022
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This study aims to evaluate the effectiveness of single buccal local infiltration when compared to buccal local infiltration with intrapapillary infiltration and inferior alveolar nerve block anesthesia in primary mandibular molar extractions.


Description:

Effective pain control is essential in providing children with successful dental treatment. Without it, negative experiences may result in anxiety and fear-related behaviors towards subsequent dental treatment. Local anesthesia is the cornerstone of pain control in dentistry. Choosing the right local anesthetic technique is of special significance . The inferior alveolar nerve block (IANB) is a common practice for anesthetizing mandibular molars and/or premolars on one side of the jaw. It is achieved by depositing local anesthetic solution at the entrance to the mandibular canal, which inhibits the transmission of action potentials along the inferior alveolar nerve. Administering an IANB can be technique sensitive and failure rates are reported to be up to 20%, due to anatomical variations in the position of the mandibular foramen and accessory innervations. This effect may be compounded for those who are not used to anesthetizing children . However, Supraperiosteal infiltration has the advantages of easier administration when compared to block anesthesia, shorter anesthetic duration, and generally does not anesthetize the lips . An ideal local anesthetic should provide maximum efficacy, through a minimal number of injections, using techniques that provide the least discomfort, causing negligible adverse effects .


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date March 3, 2022
Est. primary completion date March 1, 2022
Accepts healthy volunteers No
Gender All
Age group 5 Years to 8 Years
Eligibility Inclusion Criteria: - Badly decayed primary mandibular molars indicated for extraction with not less than half of the root length present. - Children ranging in age from 5-8 years Exclusion Criteria: .Allergies to local anesthetics. - History of significant medical conditions. - Children under any medications. - Presence of abscess, sinus opening. - Uncooperative children without access to or with difficulty accessing dental care.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Single buccal infiltration
injecting local anaesthetic solution into the soft tissues of the buccal sulcus adjacent to the target tooth.
Inferior alveolar nerve block
Injection of local anesthetic solution into the pterygomandibular space to access the inferior alveolar nerve before it enters the mandible.

Locations

Country Name City State
Egypt Cairo university Cairo

Sponsors (1)

Lead Sponsor Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of intraoperative pain Wong Baker Faces Pain Rating Scale consists of a set of cartoon faces with varying facial expressions ranging from a smile/laughter to tears with numerical value from 0 to 5 where where zero indicates no pain and 5 indicate severe pain through treatment completion, an average of 1 hour
Secondary intraoperative pain Faces, Legs, Activity, Cry, and Consolability scale with score from 0 to 10 where zero indicates no pain and 10 indicate severe pain through treatment completion, an average of 1 hour
Secondary The onset of the anesthetic effect stopwatch up to 24 hours
Secondary duration of the anesthetic effect stopwatch up to 24 hours
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